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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ring, Annuloplasty
510(k) Number K070488
Device Name MICARDIA ANNULOPLASTY BAND DR
Applicant
Micardia Corporation
30 Hughes
Suite 206
Irvine,  CA  92618
Applicant Contact JEFFREY P DUMONTELLE
Correspondent
Micardia Corporation
30 Hughes
Suite 206
Irvine,  CA  92618
Correspondent Contact JEFFREY P DUMONTELLE
Regulation Number870.3800
Classification Product Code
KRH  
Date Received02/20/2007
Decision Date 09/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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